Make your mark for patients.

We're here because we want to build the future and transform patients' lives for the better.

At UCB, our people are our experiences and achievements, our passion and drive. That's why we're looking for talented individuals with diverse backgrounds and experiences - not just the best and brightest, but those who care about making a meaningful difference in the lives of patients. We promote an environment of diversity, openness, and respect where people can make valuable contributions.

An exciting journey lies ahead. Will you join us in pushing the boundaries of what's possible?

To strengthen our Regulatory Affairs department based in our Atlanta, GA hub, we are seeking a creative and dynamic Head of US Regulatory Affairs to join our team.

The Head of US Regulatory Affairs will work with Patient Value Unit (PVU) leadership to provide therapeutic area regulatory strategies and disease state insights; regulatory vision and direction to add patient value and product differentiation; recommendations to optimize the portfolio, and leadership to establish an external network to keep abreast of trends affecting the franchise.

You like to work in an environment where you can:

• Provides regulatory oversight for therapeutic/disease area(s)
• Senior leadership and mentorship for PVU deployed Global Regulatory Leads (GRLs)
• Line manages Practice-based GRLs, regulatory science staff, labeling, advertising, and promotion staff
• Offers regulatory intelligence and policy staff within the US.
• Collaborate with all UCB regions on global regulatory strategies within therapeutic/disease areas of responsibility

You will contribute by:

• Recruit, develop, and retain highly talented and skilled regulatory scientists, labeling, advertising, promotion staff, and regulatory intelligence and policy staff.
• Responsible for providing regulatory leadership specific to the US therapeutic/disease area strategies to PVU leadership.
• Ensures regulatory resources are provided for early and late-stage development and life cycle projects (in conjunction with the GRL).
• Ensure that regulatory therapeutic/disease area strategic options, assessments, and risks specific to the US are communicated to the PVU.
• Accountable for achieving US regulatory alignment for disease area regulatory strategy with input from PVU leadership, GRLs, and Regional Leads.
• Liaise with Global Business Development regarding TA Due Diligence assignments and provide input to due diligence projects as required.
• Provide high-level strategic US regulatory direction and mentorship to GRLs, including general regulatory strategies, regulatory strategic development plans, risk assessments, and regulatory critical issue management.
• Lead special regulatory projects/process initiatives of high complexity, ensuring global alignment.
• Act as an interface between PVU and US PVO Leadership teams and GRA and build partnerships with PVU leadership and other PV Practices and Regions to ensure that strategic business goals are met through the sharing of knowledge and the provision of appropriate resources.
• Proactively manage critical issues, taking leadership for the regulatory contribution. The US region influences policies and guidance development and represents the company at key external meetings.
• Accountable for ensuring GRA provides appropriate Regulatory support in terms of talent, strategy, and tactical and operational support for the US.
• Has dotted-line reporting with PVU deployed GRLs to ensure GRL development support, right talent in the right place at the right time, and for providing very strong regulatory leadership and innovative and strategic thinking is applied
• Accountable for developing top talent within the GRA Community (direct reports and GRLs) by providing stretch goals, coaching, and mentoring for success
• Accountable for providing resources necessary to achieve PVU goals and objectives
• Responsible for developing credible and trustful relationships internally and externally, with specific emphasis on the FDA.

Interested? For this position, you'll need the following education, experience, and skills:

• Bachelor's Degree
• 15+ years of pharmaceutical industry experience. This includes 10 years of regulatory experience or a combination of 15 years of regulatory and related experience.
• US regulatory experience (Americas, EMEA; APAC a plus) required with a proven track record of significant regulatory accomplishments
• Thorough understanding of drug development process and global regulatory requirements and processes
• Up to date knowledge of the US regulatory environment; thorough understanding of the complex set of regulations within which the organization operates and awareness of the subtleties of regulations worldwide.
• Demonstrated ability to make compelling scientific and/or strategic arguments to support all regulatory aspects related to the therapeutic/disease area.

Please let us know if you have any of the following:

• 2 + years of planning horizon to ensure the needs of the business are met
• Takes action to improve processes and critiques processes and metrics for current performance and for scaling the business
• Generates new ideas and diverse approaches
• Rewards and recognizes employees and teams who take the initiative beyond expectations to advance business goals
• Takes a long-term view and makes plans for acquiring the skills and expertise needed to support the business today and, in the future.
• Must be strong overall and able to train/develop staff in the area of regulatory strategies, such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies.
• Strong in working well with others, within teams, and working with senior leadership.

#RAND

About us.

UCB is a global biopharmaceutical company, focusing on neurology and immunology. We are around 7,600 people in all four corners of the globe, inspired by patients and driven by science.

At UCB, everything we do start with a simple question: "How will this create value for people living with severe disease?". We are on a journey to become the patient-preferred biopharma leader by delivering medicines and solutions that improve lives. We want to ensure the creation of patient value, now and into the future, while contributing to a society where a population of 8 billion people and more should be able to live a good life within limited resources of one planet.

Curious to know more? Please visit our website .

Where permitted, applicants for employment in the United States must have received or be willing to receive a full COVID-19 vaccination by the date of hire; or, alternatively, agree to be subject to weekly COVID-19 testing, subject to religious and medical exemptions and in accordance with applicable law.

UCB is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, national origin, religion, gender, age, marital status, disability, veteran status, sexual orientation, gender identity, or any other characteristic protect by law.